In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of January 2026. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
1) Regulatory Update
- Centre amends NDCTR-2019 to ease rules for approval of new drugs & investigational new drugs
The Union Health Ministry has amended the New Drugs and Clinical Trials Rules, 2019 (NDCTR, 2019) to ease and expedite approvals for manufacturing new drugs and investigational new drugs. Under the revised rules, manufacturing for analytical and non-clinical testing excluding specified categories can commence after prior intimation through Form CT-10 and acknowledgment from the Central Licensing Authority (CLA), instead of requiring prior permission. Timelines for regulatory decisions have been reduced from 90 to 45 working days, including post-rectification reviews. The amendments also extend similar provisions to unapproved Active Pharmaceutical Ingredients (API) for development and testing. These changes, effective 45 days from January 20, 2026, aim to streamline regulatory processes and support faster drug development.
- CDSCO approves highest number of new drugs with r-DNA origin for import & manufacture in 2025
The Central Drugs Standard Control Organization (CDSCO) approved the highest number of new drugs of recombinant Deoxyribonucleic Acid (r-DNA) origin for import and manufacture in India during 2025, marking a significant rise over the past five years. A total of 28 r-DNA–based new drugs were approved for manufacture and marketing, compared to 20 in 2024. These included multiple insulin formulations for Diabetes Mellitus and Nimotuzumab for Head and Neck Cancer. Additionally, 44 r-DNA–origin new drugs were approved for import and marketing in 2025, up from 26 in the previous year. The approvals span products from companies such as Eris Lifesciences, Zydus Lifesciences, Biocon Biologics, AstraZeneca Pharma, Novo Nordisk, and Bristol Myers Squibb India, reflecting growing regulatory activity in biologics.
- IPA-CPD urges health ministry to amend rules to mandate red line on labels of Antibiotics
The Indian Pharmaceutical Association–Community Pharmacy Division (IPA-CPD) has urged the Union Ministry of Health and Family Welfare to amend the Drugs and Cosmetics Rules to mandate a red line marking on Antibiotic Labels, in addition to the existing Schedule H or Schedule H1 warnings. The request follows the Ministry’s Red Line Campaign highlighting the red line as a visual cue against self-medication and misuse of Antibiotics. IPA-CPD noted a regulatory inconsistency, as Antibiotic Labels currently do not carry the red line despite public advisories. The association stated that a legally mandated red line would reinforce prescription-only status, discourage misuse, and support national efforts to curb Antimicrobial Resistance (AMR). The proposal aligns with recent public health messaging on rational antibiotic use.
- DoP calls for proposals to set up common facilities for medical device clusters
The Department of Pharmaceuticals (DoP) has invited applications to establish Common Facilities for Medical Device Clusters under the Scheme for Strengthening of Medical Device Industry (SMDI). Applications for the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme must be submitted by 31 January 2026 and will be considered on a First In, First Out (FIFO) basis. Proposals are to be submitted to the Small Industries Development Bank of India (SIDBI) through the Udyam Mitra portal. Priority will be given to applicants with existing land and infrastructure seeking to strengthen testing capabilities, including functional testing, Magnetic Resonance Imaging (MRI) compatibility testing, usability engineering, and clinical performance evaluation. The DoP has also extended deadlines for two other SMDI sub-schemes to 31 January 2026 to support domestic manufacturing and clinical studies.
- DCGI releases classification of 77 medical devices related to oncology
The Drugs Controller General India (DCGI) has issued a notice classifying 77 Medical Devices related to Oncology under the Medical Devices Rules (MDR), 2017, as part of efforts to bring all medical devices under structured regulatory oversight. The devices have been categorised based on risk into four classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). The classification includes surgical consumables, diagnostic and imaging tools, software applications for Cancer detection, therapeutic systems, and high-risk technologies such as stereotactic radiosurgery systems. The notice provides general intended use for guidance in manufacturing and imports applications, while allowing manufacturers to specify device-specific use. The move aims to reduce regulatory ambiguity and strengthen patient safety.
- Union health minister releases 10th edition of Indian Pharmacopoeia 2026
Union Health Minister released the Indian Pharmacopoeia 2026 (IP 2026), the 10th edition of India’s official book of drug standards, marking a major step in strengthening pharmaceutical quality and regulation. The new edition incorporates 121 additional monographs, taking the total to 3,340, with enhanced coverage of Anti-Tubercular, Anti-Diabetic, Anti-Cancer medicines and iron supplements used under National Health Programmes. IP 2026 reflects scientific advancements, global best practices and India’s expanding role in pharmaceutical regulation. The minister highlighted India’s improved pharmacovigilance standing, rising to 8th globally in 2025 under the Pharmacovigilance Programme of India (PvPI). The standards are legally enforceable and aligned with International Council for Harmonisation (ICH) norms.
- Proposed VBSA Bill to mandate radical transparency for pharmacy education
The proposed Viksit Bharat Shiksha Adhishthan (VBSA) Bill, 2025 seeks to introduce stringent transparency and accountability norms for pharmacy education institutions in India. The Bill mandates comprehensive online and offline public disclosure of institutional data, including finances, audits, faculty credentials, and educational outcomes, through a central national portal. It empowers a new Regulatory Council to conduct time-bound enforcement and impose penalties for dishonest disclosures, financial irregularities, or sub-standard practices, with corrective action to be completed within 60 days. A robust student grievance redressal mechanism and safeguards ensuring penalties do not adversely impact students are key features. While professional oversight by the Pharmacy Council of India continues, the Bill aims to curb commercialization and uphold high-quality, transparent pharmacy education nationwide.
2) Approvals
- European Commission approves GSK’s Recombinant Zoster Vaccine, Shingrix in prefilled syringe
GSK plc announced that the European Commission (EC) has approved Shingrix, its Recombinant Zoster Vaccine (RZV), in a new prefilled syringe presentation. The approval replaces the earlier two-vial system requiring reconstitution with a simplified format, improving ease of administration for healthcare professionals without altering indication or dosing. The decision is based on data confirming technical comparability with the existing presentation. Shingrix is approved in the European Union for prevention of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) in adults aged 50 years and above, and in adults aged 18 years or older at increased risk. The vaccine helps address age-related immune decline and supports broader protection against shingles.
- UK MHRA approves Nirogacestat for Desmoid Tumours
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nirogacestat for the treatment of adults with progressing Desmoid Tumours, a rare, locally aggressive soft tissue condition with limited treatment options. The approval marks a significant regulatory milestone, as Nirogacestat becomes one of the few targeted oral therapies available for this indication. The decision follows evidence demonstrating clinically meaningful tumour reduction and symptom control, reinforcing MHRA’s commitment to facilitating access to innovative treatments for rare diseases. The approval also reflects the agency’s broader strategy to accelerate patient access while maintaining robust standards for safety and efficacy, particularly in conditions where surgery or conventional therapies carry high morbidity.
- 4 Moving Biotech receives US FDA IND clearance for Osteoarthritis Therapy
4Moving Biotech (4MB) announced that the United States Food and Drug Administration (US FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling expansion of the phase 2a INFLAM MOTION clinical trial into the United States. The clearance supports global deployment of the study across Europe, Canada, and the United States, strengthening 4MB’s position in disease-modifying Osteoarthritis (OA) drug development. 4P004 is a first-in-class intra-articular Glucagon-Like Peptide-1 (GLP-1) receptor agonist designed to address pain and underlying joint pathology. Preclinical data indicates modulation of multiple joint biomarkers, supporting its potential as a Disease Modifying Osteoarthritis Drug (DMOAD).
- China NMPA grants Breakthrough Therapy Designation to Kelun-Biotech Oncology Therapy
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA), through its Center for Drug Evaluation (CDE), has granted Breakthrough Therapy Designation (BTD) to its TROP2-directed antibody-drug conjugate Sacituzumab Tirumotecan (sac-TMT) in combination with Pembrolizumab for first-line treatment of Programmed Death-Ligand 1 (PD-L1)-positive non-small cell Lung Cancer patients without epidermal growth factor receptor or anaplastic lymphoma kinase alterations. The designation is supported by positive phase III clinical trial of ptiTROP-Lung05 data showing significant progression-free survival improvement.
- UK MHRA approves Zapomeran mRNA Covid-19 vaccine for immunisation of individuals aged 18 years of age and older
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved Zapomeran (Kostaive), a messenger Ribonucleic acid, Covid-19 vaccine, for immunization of individuals aged 18 years and above. Granted under the International Recognition Procedure (IRP), with the European Medicines Agency (EMA) as the reference regulator, the approval provides an additional booster option for adults. Zapomeran is administered as a single 0.5 milliliter intramuscular booster dose and uses self-amplifying messenger RNA (sa-mRNA) technology to induce immune protection against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The MHRA stated that vaccine safety will continue to be closely monitored, with common side effects generally mild and transient.
- UK MHRA approves up to 7.2mg dose of Semaglutide for patients with Obesity only
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved a higher maximum weekly dose of 7.2 milligrams (mg) of Semaglutide (Wegovy) for adult patients with Obesity. The approval applies only to patients with a Body Mass Index (BMI) of 30 kilograms per square metre (kg/m²) or above, in combination with a reduced-calorie diet and exercise. It excludes overweight patients with BMI below 30 kg/m² and use for reducing cardiovascular risk. Treatment starts at 0.25 mg per week, with dose escalation every four weeks to 2.4 mg. If required, the dose may be increased to 7.2 mg after a minimum of four weeks on 2.4 mg.
- Indian drugmakers get regulatory nod to sell generic Wegovy, heating obesity-drug race
Sun Pharmaceutical Industries, Zydus Lifesciences, Dr Reddy’s and Alkem Laboratories have received regulatory approval in India to manufacture and market generic versions of Semaglutide, the active ingredient in Novo Nordisk’s blockbuster weight-loss and diabetes drugs Wegovy and Ozempic. Sun Pharma has announced plans to launch its generics under the brands Noveltreat (obesity) and Sematrinity (diabetes). Approvals come ahead of Semaglutide’s patent expiry in March 2026, paving the way for lower-priced alternatives. The entry of generics is expected to intensify competition, expand patient access through aggressive pricing, and accelerate growth in India’s rapidly emerging Obesity and Diabetes treatment market.
- USFDA approves first oral treatment for Anemia in thalassemia
The U.S. Food and Drug Administration has approved Aqvesme (mitapivat) tablets for the treatment of Anemia in adults with alpha- or beta-thalassemia, marking the first oral therapy for beta-thalassemia and the first approved drug for alpha-thalassemia. Approval was based on two Phase III trials. In transfusion-dependent patients, Aqvesme achieved a significant reduction in transfusion needs compared to placebo. In non-transfusion-dependent patients, it significantly improved hemoglobin levels and reduced fatigue. Aqvesme is administered orally at 100 mg twice daily and is available only through a Risk Evaluation and Mitigation Strategy (REMS) due to liver toxicity risk.
- Digital integration advances insulin delivery solutions
Medtronic has received clearance from the U.S. Food and Drug Administration for its MiniMed Go app, which connects Medtronic’s smart insulin pens with a continuous glucose monitor from Abbott. The app provides missed-dose alerts, dose calculations, clinical guidance, and provider-facing reports to support glycemic control for people using insulin pens. Medtronic plans to launch the app in spring 2026. A retrospective analysis showed improved time-in-range among users who acted promptly on alerts.
3) International Pharma News
- World Council of Optometry and Alcon expand partnership to promote dry eye disease education
The World Council of Optometry (WCO) and Alcon have expanded their partnership to strengthen global professional education on dry eye disease, renewing their initiative for the fourth consecutive year. Launched in 2022, the collaboration focuses on improving the mitigation, measurement, and management of dry eye disease, which affects an estimated 1.6 billion people worldwide. Through digital tools, webinars, and the interactive WCO–Alcon Dry Eye Wheel, the initiative supports optometrists in early identification and effective care. Both organizations emphasized that enhanced education is critical to addressing the rising prevalence of dry eye disease and improving patient quality of life globally.
- WHO renews commitment to a Leprosy-Free world, spotlighting partnership and progress ahead of World Leprosy Day
The World Health Organization (WHO) reaffirmed its commitment to a Leprosy-free world ahead of World Leprosy Day on 25 January, emphasizing access to treatment, partnerships, and stigma reduction. Leprosy, caused by Mycobacterium leprae, remains curable through Multidrug Therapy (MDT), yet 172,717 new cases were reported globally in 2024 despite progress in several regions. WHO highlighted its long-standing collaboration with Novartis, which has supplied MDT and clofazimine free of cost since 2000. Marking 25 years of partnership, both parties extended their Memorandum of Understanding (MoU) for 2026–2030, including support for Single Dose Rifampicin (SDR) for Post-Exposure Prophylaxis (PEP). The efforts align with global Neglected Tropical Diseases (NTDs) elimination strategies.
- Lupin and Galenicum ink license and supply agreement for Semaglutide in 23 countries
Lupin Limited has entered into a licensing and supply agreement through its subsidiary Lupin Atlantis Holdings SA with Galenicum Health, S.L.U. for finished formulations of injectable Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) receptor agonist. Under the agreement, Galenicum will manage development, manufacturing, and supply, while Lupin will be responsible for regulatory submissions, approvals, commercialization, and distribution across 23 countries, including Canada, Europe, Southeast Asia, and Latin America. The partnership supports Lupin’s expansion in Diabetes and Obesity care beyond India. Semaglutide is primarily used in adults with Type 2 Diabetes and for long-term weight management in Obesity and overweight conditions. The collaboration aims to scale global access to cost-effective GLP-1 therapies amid rising demand.
- World Health Organization releases updated recommendations on HIV clinical management
The World Health Organization (WHO) has released updated recommendations on Human Immunodeficiency Virus (HIV) clinical management, providing revised guidance on Antiretroviral therapy, prevention of vertical Transmission, and Tuberculosis (TB) prevention. The update confirms dolutegravir-based regimens as the preferred option for initial and subsequent HIV treatment and recommends Darunavir/Ritonavir as the preferred protease inhibitor when required. It supports reuse of Tenofovir and Abacavir in later regimens and introduces long-acting injectable Antiretroviral therapy and oral two-drug regimens for selected, clinically stable patients. For TB prevention, WHO now recommends three months of weekly isoniazid plus rifapentine as the preferred regimen. The guidance aims to simplify care, improve adherence, and reduce HIV- and TB-related mortality globally.
- Cognizant secures over USD 1 billion IT services deal from Novartis
Cognizant is learnt to have secured a consolidation contract worth over USD 1 billion from Swiss pharma major Novartis, covering renewals and expanded scope across application services, infrastructure, data, and Artificial Intelligence (AI)-led offerings. This marks Cognizant’s second billion-dollar deal in under a year, following a large contract with UnitedHealth Group. Sources indicated that Cognizant’s Europe, Middle East and Africa (EMEA) and Asia-Pacific (APAC) teams played a key role in winning the deal. Industry experts note that such mega-deals reflect enterprises consolidating vendors into fewer, long-term contracts for stronger accountability, rather than a surge in discretionary IT spending, according to HfS Research.
- Bristol Myers Squibb collaborates with Microsoft to advance AI-driven early detection of Lung Cancer
Bristol Myers Squibb (BMS) has entered into a digital health collaboration with Microsoft to advance Artificial Intelligence (AI) driven early detection of Lung Cancer in the United States. Under the agreement, United States Food and Drug Administration (US FDA) cleared radiology AI algorithms will be deployed through Microsoft’s Precision Imaging Network to analyze X-ray and Computed Tomography (CT) images and identify hard-to-detect lung nodules. The initiative aims to support radiologists, reduce clinical workload, and improve early diagnosis of Non-Small Cell Lung Cancer (NSCLC), particularly in medically underserved communities. By integrating workflow management tools to track patients with incidental findings, the collaboration seeks to reduce loss to follow-up, promote health equity, and enable timely access to appropriate care pathways and precision therapies.
- Illumina introduces Billion Cell Atlas to accelerate AI and drug discovery
Illumina has introduced the Billion Cell Atlas, the world’s largest genome-wide genetic perturbation dataset designed to accelerate Artificial Intelligence (AI)-driven drug discovery. Developed with founding partners AstraZeneca, Merck and Eli Lilly and Company, the initiative marks the first phase of a planned five-billion-cell atlas. The dataset captures how one billion cells respond to clustered regularly interspaced short palindromic repeats based genetic perturbations across more than 200 disease-relevant cell lines. The Atlas will support drug target validation, precision medicine research, and large-scale AI model training, enabling deeper insights into complex disease biology and faster translation from discovery to clinical development.
- Abbott’s new Libre Assist app feature tackles a top need for people living with diabetes
Abbott has introduced Libre Assist, a new feature within the Libre app, aimed at helping people living with Diabetes make informed, in-the-moment food decisions. Launched at the Consumer Electronics Show (CES) 2026, Libre Assist uses generative Artificial Intelligence (AI) to predict how meals may impact glucose levels before consumption, offering personalised guidance through photo or text-based inputs. The feature integrates with Abbott’s FreeStyle Libre continuous glucose monitoring (CGM) systems to validate actual post-meal glucose responses, helping users understand individual food reactions. By combining predictive insights with real-time glucose data, Libre Assist supports proactive diabetes self-management without additional cost, subscription, or prescription, reinforcing Abbott’s focus on personalised digital health innovation.
4) Domestic Pharma News
- Telangana sets global ambition with Next Gen Life Sciences Policy 2026–30
The Government of Telangana unveiled its Next-Gen Life Sciences Policy 2026–30 at the World Economic Forum Annual Meeting in Davos, signaling a strategic shift towards value-led, innovation-driven growth in life sciences. The policy aims to position Telangana among the top five global life sciences clusters by 2030, targeting investments of USD 25 billion (Twenty-Five) Billion and creation of 500,000 (Five Lakh) jobs high-quality jobs. It emphasizes advanced research and development (R&D), frontier science, and sustainable bio-manufacturing, including cell and gene therapies, precision fermentation, and digital health. Key initiatives include recognition of R&D units as industrial enterprises, a Life Sciences Innovation Fund of up to INR 1,000 crore (One Thousand) Crore and globally benchmarked infrastructure such as Green Pharma City and Genome Valley expansion.
- Lupin receives highest ESG rating from CDP for Climate Change and Water Security
Lupin Limited has received the highest ‘A’ leadership rating from the Climate Disclosure Project (CDP) for its performance in Climate Change and Water Security, reinforcing its position among global sustainability leaders. The double ‘A’ rating reflects Lupin’s focused efforts to mitigate climate risks, reduce carbon emissions, and ensure responsible water management across its operations. This marks a significant improvement over earlier ratings of ‘A-’ in 2024 and ‘B’ for climate and ‘C’ for water in 2023, demonstrating strong year-on-year progress. In addition to the CDP recognition, Lupin achieved an S&P Global Environmental, Social and Governance (ESG) score of 91 in 2025, placing it among a select group of companies worldwide with best-in-class sustainability performance.
- Tamil Nadu’s proactive safety vigilance becomes new national standard for oral liquid medications
Tamil Nadu Drugs Control Department’s proactive safety measures for Oral Liquid medications have emerged as a national benchmark for pharmaceutical vigilance. The state had institutionalised routine testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in complaint-based samples well before central mandates, enabling early detection of toxic contaminants. This protocol proved critical in identifying an adulterated batch of Coldrif cough syrup, preventing potential public health harm, particularly risks of Acute Kidney Failure in paediatric use. The approach has now been adopted nationally; this move strengthens preventive drug safety standards across India.
- HRV Pharma and Haleos Labs inks CDMO alliance to fast-track Orphan Drug & Niche API development
HRV Global Life Sciences has entered into a multi-year strategic Contract Development and Manufacturing Organisation (CDMO) partnership with Haleos Labs (formerly SMS LifeSciences) to accelerate the development of Orphan drug and Niche Therapeutic Active Pharmaceutical Ingredients (APIs). The alliance focuses on end-to-end Good Manufacturing Practice (GMP) development, scale-up, and commercial manufacturing for regulated and semi-regulated markets. It combines HRV’s global market access and virtual API platform with Haleos Labs’ chemistry expertise and World Health Organization–Good Manufacturing Practice (WHO-GMP) compliant manufacturing capabilities. The partnership targets five to seven new molecules annually across rare diseases, central nervous system and metabolic disorders, supported by global regulatory filings including Drug Master Files (DMFs) for major international regulators.
- Manipal Hospital Gurugram launches ‘Kawach’, a community-health screening programme
Manipal Hospital Gurugram, in collaboration with Manipal Foundation, has launched ‘Kawach’, a community-based cancer screening programme aimed at improving early diagnosis among underserved women in Gurugram. The initiative will screen around 5,000 women aged 18–65 years across multiple villages, focusing on oral, breast, and cervical cancers alongside general wellness checks. Women identified with suspicious symptoms will be referred to nearby hospitals for further evaluation and treatment. The programme emphasises preventive healthcare, early detection, and continuity of care through structured screening, on-ground counselling, and referral support, helping reduce late-stage cancer diagnoses and improve long-term health outcomes for women in the region.
- IPC’s relaunch of toll-free helpline as a multilingual IVR system to improve ADR reporting
Indian Pharmacopoeia Commission (IPC) has relaunched its toll-free helpline (1800-180-3024) as a multilingual Interactive Voice Response System (IVRS) under the Pharmacovigilance Programme of India (PvPI) to strengthen Adverse Drug Reaction (ADR) reporting and patient safety. The upgraded system enables ADR reporting related to medicines, vaccines and medical devices in 10 Indian languages, improving accessibility and public participation. It also supports bilingual query resolution on Indian Pharmacopoeia (IP), IP Reference Standards (IPRS) and National Formulary of India (NFI), including monographs, calibrator tablets and proficiency testing programmes. Available on working days, the initiative aims to enhance pharmacovigilance awareness, responsiveness and data-driven regulatory decision-making across India.
- AI-Driven Pharma Innovation Summit 2026 held over two days in Hyderabad
The AI-Driven Pharma Innovation Summit 2026 was held over January 22–23 in Hyderabad, highlighting the transformative role of Artificial Intelligence (AI), smart manufacturing and digital technologies in the pharmaceutical sector. Jointly organised by the Indian Drug Manufacturers’ Association (IDMA) Telangana State Board, Operant Pharmacy Federation, Chronicle Pharmabiz and Pharmabharath, the summit brought together industry leaders, scientists, technologists, startups and policymakers. Discussions on the first day focused on AI-enabled drug discovery, manufacturing, quality, supply chains and precision medicine. The second day explored the industry’s transition from Pharma 4.0 to Pharma 5.0, covering AI-driven decision-making, clinical trials, smart factories and digital strategies. The summit reinforced India’s push towards future-ready, AI-enabled pharmaceutical innovation.
- Apollo Hospitals signs MoU with Roche Diagnostics India to advance digital innovation in clinical care at THIT 2026
Apollo Hospitals Enterprise Ltd. has signed a Memorandum of Understanding (MoU) with Roche Diagnostics India at THIT 2026 to advance digital innovation in clinical care through the use of artificial intelligence (AI). The collaboration will deploy Roche’s cloud-based navify Algorithm Suite across Apollo’s clinical systems to support early diagnosis, generate patient-centric insights, and improve clinical workflow efficiency through integration with electronic medical records, laboratory information systems, and hospital information systems. The partnership will focus on real-world testing and validation of AI-driven algorithms across Apollo’s innovation and research centers. By combining Apollo’s clinical expertise with Roche’s diagnostic and digital capabilities, the initiative aims to enable more precise, timely, and personalized patient care at scale.
5) Innovations
- Onward Medical completes dual BCI implants to restore thought-driven movement
Onward Medical N.V. announced the successful completion of two additional implants of its investigational ARC-Brain-Computer Interface (BCI) Therapy in individuals living with spinal cord injury (SCI), bringing the total number of human implants to seven. The procedures, conducted at Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland, combined BCI technology with spinal cord stimulation to enable thought-driven restoration of upper- and lower-limb movement. The ARC-BCI platform uses Artificial Intelligence (AI) to decode motor intent signals from the brain and wirelessly stimulate targeted spinal cord regions. The system holds Breakthrough Device Designation (BDD) from the United States Food and Drug Administration (FDA) and is supported by over eight years of human safety data.
- Bright Minds reports positive Phase 2 results for BMB-101 in Absence Seizures and DEE
Bright Minds Biosciences announced positive Phase 2 clinical trial results for BMB-101 in patients with Absence Seizures and Developmental and Encephalopathic Epilepsies (DEE), demonstrating significant anti-seizure efficacy with a favorable safety and tolerability profile. In the Absence Seizures cohort, BMB-101 achieved a 73.1% median reduction in absence seizures lasting three seconds or more (p = 0.012), while DEE patients recorded a 63.3% median reduction in major motor seizures. Notably, patients with Absence Seizures also showed a mean 90% increase in rapid eye movement (REM) sleep without changes in total sleep duration. Based on these encouraging outcomes, the company has initiated preparations for global registrational trials in both indications.
6) Trends
- Community screening study could prevent emergency diagnoses in children with type 1 Diabetes
A National Institute for Health and Care Research (NIHR) delivered community screening study in the United Kingdom has shown potential to prevent emergency diagnoses of type 1 Diabetes in children. The Early Surveillance for Autoimmune diabetes (ELSA) study, launched in 2022, screens children aged 3 to 13 for autoantibodies that can appear years before symptoms. Among over 17,000 children screened, 160 showed early-stage type 1 Diabetes and seven had previously undiagnosed disease requiring immediate insulin. Published in the Lancet Diabetes and Endocrinology, the findings highlight the value of early detection in preventing Diabetic Ketoacidosis. The second phase, ELSA 2, will expand screening to children aged 2–17.
- India bolsters medical transportation with technology to bring in reliability in patient travel
India is strengthening medical transportation for chronic care patients through technology-led solutions that improve reliability, safety, and coordination. The emergence of organized Non-Emergency Medical Transportation (NEMT) platforms is addressing challenges such as missed appointments, long travel times, and patient anxiety. Features such as Global Positioning System (GPS) tracking, real-time route optimization, telemedicine support, and trained attendants are improving patient experience and adherence to care. Artificial Intelligence (AI)-driven scheduling and predictive analytics help hospitals manage peak demand, while digital records and cashless payments enhance efficiency. Tech-enabled NEMT is also bridging access gaps in semi-urban and rural areas. With electric fleets and Internet of Things (IoT)-enabled monitoring gaining traction, medical transport is becoming a critical pillar of chronic care delivery in India.
- Pronto Consult observes India’s 2025 healthcare shift from reactive protection to aspirational prevention
Pronto Consult has observed a significant shift in India’s healthcare behaviour during 2025, moving from reactive treatment towards aspirational and preventive health management. According to its year-end analysis, consumers prioritised routine care for chronic conditions such as Cardiac Disorders, Diabetes, and Hypertension, reflecting a focus on health stability. Respiratory health spending closely followed air quality index trends, while mental health consumption grew discreetly through digital platforms. A notable change was the emergence of glucagon-like peptide-1 (GLP-1) and metabolic therapies as aspirational purchases aimed at long-term health transformation. Over-the-counter products and daily wellness solutions gained prominence, signalling a transition towards anticipation, routine prevention, and self-managed healthcare as India enters 2026.
- UK MHRA statement on new review of Paracetamol safety during pregnancy
The Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed the safety of Paracetamol use during pregnancy following a new systematic review and meta-analysis published in the Lancet Obstetrics, Gynaecology, & Women’s Health. The review found no evidence linking Paracetamol exposure in pregnancy with increased risk of Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD), or Intellectual Disability in children. The MHRA stated that Paracetamol remains the recommended first-line treatment for pain and fever during pregnancy when used at the lowest effective dose for the shortest duration. The agency emphasized ongoing safety monitoring and advised pregnant women to consult healthcare professionals if symptoms persist, while cautioning against untreated pain or fever due to potential risks to the unborn child.
- Study involving clinical psychologists shows more young adults arrive with desired diagnoses
A new mixed-methods study led by Karl Landsteiner University (KL Krems), involving 93 clinical psychologists in Austria, finds that an increasing number of young adults now seek psychological assessments with a pre-determined or self-assigned diagnosis, most commonly attention deficit hyperactivity disorder and autism spectrum disorder. The trend is particularly observed among young, highly educated women with intensive social media use. Clinicians report that social media platforms and online self-tests strongly shape expectations, often leading to “diagnosis shopping” when clinical findings do not align with patient beliefs. The study highlights growing challenges in mental health assessments and underscores the need for improved communication, transparency, and training to balance diagnostic integrity with patient well-being.
7) Law and Order Briefs
- Galderma provides update on arbitration case regarding Neuromodulator research and development partnership
Galderma announced that an International Chamber of Commerce (ICC) arbitral tribunal has issued an award confirming the termination of its 2014 Neuromodulator research and development partnership with Ipsen, limited to early-stage Neuromodulator pipeline rights for aesthetic indications. The company welcomed the clarity provided by the tribunal, stating that the decision has no impact on the commercialization of its Neuromodulator portfolio. Galderma will continue to commercialize and supply Dysport/Azzalure, Alluzience, and Relfydess in approved markets under existing agreements with Ipsen.
- DCA Telangana raids illegal clinic in Hanumakonda, antibiotics and steroids seized
The Drugs Control Administration Telangana conducted a raid on an illegal clinic in Hanumakonda district, uncovering the unauthorized sale of medicines by an unqualified practitioner. During the operation, officials seized around 30 varieties of drugs, including antibiotics, steroids, analgesics, anti-ulcer and antihypertensive medicines, valued at approximately INR 21,650 (Rupees Twenty-One Thousand Six Hundred Fifty), all stocked without a valid drug license. The DCA raised serious concerns over indiscriminate antibiotic use contributing to antimicrobial resistance and the health risks associated with unsupervised steroid administration. Samples have been sent for laboratory analysis, and legal action has been initiated under the Drugs and Cosmetics Act, 1940. The regulator also warned wholesalers against supplying medicines to unlicensed entities.
- AIOCD urges PM to shut down illegal e-pharmacies amid rising antibiotic resistance
The All-India Organisation of Chemists and Druggists (AIOCD) has urged Prime Minister Narendra Modi to intervene and shut down illegally operating e-pharmacies, citing rising Antimicrobial Resistance (AMR) as a serious public health threat. And findings of the Indian Council of Medical Research (ICMR), the AIOCD alleged that several online platforms are violating the Drugs and Cosmetics Act, 1940 by selling prescription medicines, including antibiotics, without valid prescriptions. The body also pointed to misuse of telemedicine norms and inadequate enforcement despite court observations, warning that unchecked online sales are accelerating self-medication, treatment failure, and strain on India’s healthcare system.
- Novo Nordisk announces China’s Supreme People’s Court delivers positive ruling on Semaglutide compound patent
Novo Nordisk announced that China’s Supreme People’s Court has delivered a favourable ruling upholding the validity of the Semaglutide compound patent, affirming an earlier decision of the Beijing Intellectual Property Court. The judgment reinforces intellectual property protection for Semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) analogue developed by Novo Nordisk and used in medicines such as Wegovy, Ozempic, and Rybelsus. The company stated that the ruling demonstrates strong government support for medical innovation and enhances confidence for foreign pharmaceutical companies operating in China. Novo Nordisk clarified that the decision does not change its previously communicated expectations regarding the impact of semaglutide patent expires on global sales growth.
- Haryana FDA seizes large stock of Tapentadol and Pregabalin in Sirsa and Chautala raids
The Haryana Food and Drug Administration (FDA) has intensified enforcement action against the illegal sale of habit-forming medicines, seizing large quantities of Tapentadol and Pregabalin during raids in Sirsa and Chautala. Acting on complaints, drug inspectors conducted joint operations with local authorities, confiscating over 2,600 tablets and capsules after retailers failed to produce valid purchase and sale records. The seizures were carried out under Form-17, with legal action initiated under the Drugs and Cosmetics Act, 1940. State Drugs Controller Lalit Kumar Goel stated that the raids are part of a sustained zero-tolerance drive to prevent diversion of psychotropic drugs. The campaign also includes action on overpricing, labelling violations, and plans for interstate coordination to curb spurious drug trade.
- BDCDA calls on retailers & wholesalers to uphold ethical trade, steer clear of illegal practices
The Bangalore District Chemists and Druggists Association (BDCDA) has urged retailers and wholesalers to strictly follow ethical trade practices and avoid illegal activities in 2026. Citing issues such as counterfeit medicines, contaminated syrups, diversion of narcotic formulations, and unregulated online drug sales, the association highlighted serious risks to public health and the credibility of the pharmacy trade. BDCDA called for full legal compliance, transparency, and responsible distribution to restore trust and safeguard consumers.
- FIPO lodges complaint with PCI against unauthorized pharmacy assistant courses in north Kerala
The Kerala branch of the Federation of Indian Pharmacists’ Organizations (FIPO) has filed a complaint with the Pharmacy Council of India (PCI) against institutions in Malappuram district conducting unauthorized ‘Pharmacy Assistant’ courses. FIPO warned that these courses operate outside the Pharmacy Act, lack accreditation, and mislead students with certificates that have no legal or professional validity. Graduates are ineligible for State Pharmacy Council registration and cannot practice as pharmacists. The complaint seeks a complete ban on such unrecognized programs to protect students, uphold education standards, and ensure public healthcare and safety.
